BREATHING ASSISTANCE APPARATUS
20180001047 · 2018-01-04
Inventors
- Alastair Edwin McAuley (Auckland, NZ)
- Christopher Earl Nightingale (Auckland, NZ)
- Lewis George Gradon (Auckland, NZ)
- Mark Joseph Haycock (Te Awamuto, NZ)
- Nicholas Charles Alan Smith (Auckland, NZ)
- Daniel Mahon (Auckland, NZ)
- Fiona Elizabeth Cresswell (Auckland, NZ)
Cpc classification
A61M16/0493
HUMAN NECESSITIES
A61M16/0616
HUMAN NECESSITIES
A61M16/08
HUMAN NECESSITIES
A61M16/1045
HUMAN NECESSITIES
A61M16/0069
HUMAN NECESSITIES
A61M16/0488
HUMAN NECESSITIES
International classification
A61M16/08
HUMAN NECESSITIES
A61M16/00
HUMAN NECESSITIES
Abstract
A CPAP system for supplying humidified gases to a user is disclosed in which various interfaces are described for gas delivery. A mask cushion including a deformable cushion and thin sheath is described.
Claims
1. (canceled)
2. An elbow connector adapted to connect a patient interface with a supply of gases, the elbow connector comprising: a hollow body having an inlet and an outlet, the hollow body defining an air flow channel, the inlet configured to be in fluid communication with the supply of gases in use and the outlet configured to be in fluid communication with the patient interface in use; a wall of the hollow body defining the air flow channel, the wall being cylindrical, the cylindrical wall having a proximal portion closest to a user and a distal portion furthest from the user, the cylindrical wall also having a curved portion that bends in a first direction such that a length of the distal portion is longer than a length of the proximal portion, the distal portion comprising a flexible thin portion along the curved portion of the cylindrical wall such that the flexible thin portion is curved in two dimensions; and the thin portion comprising a plurality of apertures configured to externally vent gases exhaled by the user.
3. The elbow connector of claim 2, wherein the elbow connector has at least a portion formed from polycarbonate.
4. The elbow connector of claim 2, wherein the elbow connector has at least a portion formed from Hytrel plastic.
5. The elbow connector of claim 2, wherein the apertures have rounded peripheries.
6. The elbow connector of claim 2, wherein the plurality of apertures are configured to reduce noise caused by venting of the gases exhaled by the user.
7. The elbow connector of claim 2, wherein the plurality of apertures are arranged in a circle.
8. The elbow connector of claim 7, wherein the flexible thin portion is circular.
9. An elbow connector adapted to connect a patient interface with a supply of gases, the elbow connector comprising: a hollow body having an inlet and an outlet, the hollow body defining an air flow channel, the inlet configured to be in fluid communication with the supply of gases in use and the outlet configured to be in fluid communication with the patient interface in use, the hollow body comprising a thin portion positioned along a curved portion of the elbow connector, the thin portion being thinner in cross section than an adjacent portion of the hollow body, the thin portion comprising a plurality of apertures configured to externally vent gases exhaled by the user.
10. The elbow connector of claim 9, wherein the material that forms the elbow connector has an increasing flexibility with a decreasing thickness.
11. The elbow connector of claim 10, wherein the elbow connector comprises at least a portion formed from polycarbonate.
12. The elbow connector of claim 11, wherein the thin portion is more flexible than the remainder of the hollow body.
13. The elbow connector of claim 10, wherein the elbow connector comprises at least a portion formed from Hytrel plastic.
14. The elbow connector of claim 13, wherein the thin portion is more flexible than the remainder of the hollow body.
15. The elbow connector of claim 9, wherein the thin portion is located in a distal portion of the hollow body positioned away from the user in use.
16. The elbow connector of claim 15, wherein the plurality of apertures are arranged in a circle.
17. The elbow connector of claim 16, wherein the thin portion is circular.
18. The elbow connector of claim 17, wherein the apertures have rounded peripheries.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0031] Preferred forms of the present invention will now be described with reference to the accompanying drawings.
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DETAILED DESCRIPTION
[0055] The present invention provides improvements in the delivery of CPAP therapy. In particular a patient interface is described which is quieter for the user to wear and reduces the side leakage as compared with the prior art. It will be appreciated that the patient interface as described in the preferred embodiment of the present invention can be used in respiratory care generally or with a ventilator but will now be described below with reference to use in a humidified CPAP system. It will also be appreciated that the present invention can be applied to any form of patient interface including, but not limited to, nasal masks, oral masks and mouthpieces.
[0056] With reference to
[0057] Controller 9 receives input from sources such as dial 10 through which a user of the device may, for example, set a predetermined required value (preset value) of humidity or temperature of the gases supplied to patient 1. The controller may also receive input from other sources, for example temperature and/or flow velocity sensors 11 and 12 through connector 13 and heater plate temperature sensor 14. In response to the user set humidity or temperature value input via dial 10 and the other inputs, controller 9 determines when (or to what level) to energise heater plate 7 to heat the water 6 within humidification chamber 5. As the volume of water 6 within humidification chamber 5 is heated, water vapour begins to fill the volume of the chamber above the water's surface and is passed out of the humidification chamber 5 outlet 4 with the flow of gases (for example air) provided from blower 15 which enters the chamber through inlet 16. Exhaled gases from the patient's mouth are passed directly to ambient surroundings in
[0058] Blower 15 is provided with variable speed fan 21 which draws air or other gases through blower inlet 17. The speed of variable speed fan 21 is controlled by electronic controller 18 (or alternatively the function of controller 18 could carried out by controller 9) in response to inputs from controller 9 and a user set predetermined required value (preset value) of pressure or fan speed via dial 19.
Nasal Mask
[0059] According to a first embodiment of the present invention the patient interface is shown in
[0060] The hollow body 102 is constructed of a relatively inflexible material for example, polycarbonate plastic. Such a material would provide the requisite rigidity as well as being transparent and a relatively good insulator. The expiratory gases can be expelled through a valve (not shown) in the mask, a further expiratory conduit (not shown), or any other such method as is known in the art.
Mask Cushion
[0061] Referring now to
[0062] In
[0063] In the preferred embodiment, shown in
[0064] The outer sheath 1112 fits in place over the cushion 1110, holding it in place. The sheath 1112 is secured by a snap-fit to the periphery 1114 of the hollow body. In
Forehead Rest
[0065] In the preferred embodiment of the present invention the nasal mask 2102 includes a hinged forehead rest 2106 (seen in
[0066] In one form shown in
[0067] At the top end 2142 (around the user's forehead) of the bridge member 2136 harnessing slots 2138 are provided which allow straps from the headgear to be inserted to secure the mask to the headgear. For the users comfort one or more resilient cushions 2140 are provided underneath the top end 2142 of the bridge member 2136, which rest on the forehead of the user. The cushion 2140 might be constructed of silicon or any foam materials as is known in the art for providing cushioning.
[0068] For example the forehead rest 2106 described previously may include a weakened section at its base 2132 which allows the joining member 2136 to pivot from the nasal mask 2102. The bridge member extends up to the forehead of the user. In a further alternative the mask may include a vertical upwardly extending inlet. In this case the member 2136 is hinged at its base 2132 to either side of the inlet passage. Again the member would then extend to the forehead. Alternatively any well-known form of hinge can be used to provide the pivoting action.
Mouthpiece
[0069] Now with reference to a further inlet embodiment of the present invention the patient interface 2 is shown in
[0070] A notch 60 is provided centrally in the upper edge of the vestibular shield 49 to accommodate the upper frenal attachment. A slight bead 61 is provided around the edge of the vestibular shield 49 for user comfort, with the vestibular shield 49 otherwise being very thin for additional suppleness.
[0071] Referring particularly to
[0072] Referring now to
[0073] Referring now to
[0074] The outer flap 110 is seen in
[0075] In
[0076] It will be appreciated that as well as providing a substantially airtight seal the addition of the outer flap provides enough compressive force on the mouth to keep the mouthpiece and conduit in place without the need for straps. This allows the administering of CPAP therapy to be considerably less obtrusive than traditional methods.
[0077] In a further additional improvement shown in
Interface Connection
[0078] Attention is now directed to
[0079] The connection 40 as provided in the present invention between the breathing circuit 41 and the interface 2 decouples the interface 2 from the breathing circuit 41. As a result, the connection 40 is effective in reducing the forces placed on the interface 2 by the breathing circuit 41 when the user moves around during sleep. In the preferred sleeping position, the breathing circuit 41 is laid across the chest 43 of the user, and may be scented to the user's bed clothes or sleeping garments. The breathing circuit 41 is preferably laid on the chest of the user to take the weight of the breathing circuit 41 off of the interface 2.
[0080] To connect between the gases outlet 42 which is vertical when the user is lying on his or her back and the breathing circuit 41 which is generally horizontal, an L-shaped elbow 45 is incorporated in the connection 40. The elbow 45 may be incorporated in the interface 2. The elbow 45 is formed at a right angle and provides a positive pressure on the interface 2. The elbow 45 may include a swivel joint and may be disconnected from gases outlet 42. The connection 40 further includes an extremely flexible connecting tube 46 provided between the elbow 45 and the breathing circuit 41. The connecting tube 46 is preferably connected to the breathing circuit 41 by a swivel joint 48 for reasons described herein. The breathing circuit 41, while flexible, will necessarily be stiff enough to maintain its integrity over comparatively long lengths, while the connecting tube 46, being only a short length, for example 10 centimeters, merely has to span between the user's mouth and chest, and can thereby be made in a manner that would not be suitable for long lengths. Furthermore, as a result of the short length of the connecting tube 46, the connecting tube 46 does not need to incorporate significant insulation or heating capability. The connecting tube 46 may be formed from a thin plastic membrane supported over a helical or double helical or corrugated supporting ribs. In such a case, the support makes the connection tube 46 laterally flexible and resistant to torsion. The elbow swivel joint 45 allows for movement of the connection tube 46 relative to the interface 2. The swivel joint 48 allows for movement of the connection tube 46 relative to the breathing circuit 41. It is to be understood that one or both of the swivel joints 45, 48 could be eliminated, but the preferred embodiment includes swivel joint 48.
Outlet Vent
[0081] The present invention will now be described with reference to the various different embodiments previously described. In order to reduce the noise caused by expiratory gases being expelled from the patient interface 2, the present invention is illustrated in
[0082] Referring particularly now to
[0083] Referring now to
Flow Diffuser
[0084] Referring now particularly to the use of mouthpieces, a further improvement is shown in
[0085] As described in the preceding embodiments, the mouthpiece sits with a vestibular shield 502 between the gums 504 and the lips 506 of a user. An outer flap 508 provides compressor force on the lips 506 to keep the mouthpiece in place in the user's month. Again the mouthpiece includes a tongue depressor 514 extending into the user's oral cavity.
[0086] In the preceding embodiments the delivered gases would flow through passageway 512 in the mouthpiece, causing a relatively concentrated flow of gases to flow through the oral cavity and down the airway. With the flow diffuser 500 fitted overtop of the passageway 512 the flow is defused over the much larger area of the diffuser 500, and therefore both the speed and side effects are reduced.
[0087] Alternatively the space between the passageway 512 and the diffuser 500 could be filled with a Humidity Moisture Exchange (HME) material. This would allow moisture through on the inspiratory flow put prevent it passing out an expiration. This would further prevent against the patient's passageways drying out. Further, if the HME material was in the form of foam, then it might also act as the diffuser 500. It will also be appreciated that the HME material could be used in the space 516 all the way out to the elbow connector (not shown) to maximise its effect.
[0088] It will be appreciated that by providing such a system the present invention effectively minimises the noise generated by the outward flow of expiratory gases from the mask. The present invention requires little or no maintenance. The present invention also provides a flow diffuser for use with the mouthpiece, which reduces any side effects of orally delivered CPAP therapy and improves user comfort.
Scented Seal
[0089] A scent may be applied to a cushion for a patent interface. Using the mask cushion of
[0090] During the moulding of the inner cushion or outer sheath a scent may be added via a dosing unit on the moulder before the material making up the cushion of sheath is injected into the mould. The scent therefore mixes with the material during moulding. Alternatively, the scent may be blended with the raw materials for the cushion or sheath. Or the cushion or sheath may be scented by soaking a finished product, for example, an inner cushion or outer sheath, or other type of seal for a patient interface, in a solution. In particular, vanilla is a scent that would be preferred. However, other scents could also be used.
[0091] Alternatively, a scent may be sprayed or otherwise applied to a cushion, sheath or seal.
[0092] Vanilla would be a preferred scent to be used with a patient interface cushion or seal as it has been shown that a high percentage of the human population like or at least do not have an aversion to the smell of vanilla.
[0093] In a preferred form a silicone seal, similar to that of the outer sealing sheath of
[0094] A scent may be applied to any type of seal for a patient interface. An example of a patient interface where the seal and/or cushion may be scented are the full face masks of co-pending U.S. patent application Ser. Nos. 11/368,004 and 61/104,401 of Fisher & Paykel Healthcare Limited, the contents of which are included herein by reference. Another example of a patient interface where a scent may be applied to the cushion and/or seal are the nasal cannula of co-pending U.S. patent application Ser. Nos. 10/598,026, 61/082,877 and 61/052,362 of Fisher & Paykel Healthcare Limited, the contents of which are included herein by reference. Yet another example is a seal and/or cushion that may be scented is that of the nasal mask of co-pending U.S. patent application No. 61/138,194 of Fisher & Paykel Healthcare Limited, the contents of which are included herein by reference.
Seal with Antibacterial Properties
[0095] Similar to that above, an antibacterial solution may be applied to a cushion for a patient interface.
[0096] In much the same way as detailed above in relation to adding a scent to a cushion an antibacterial solution could be added to a seal so as to give it additional antibacterial properties such that a seal having this solution in it is less likely to retain bacteria.
[0097] So as with the above scent the antibacterial solution may be blended with raw materials making up the scent, may be added during the moulding of the seal through a dosing unit or be impregnated by soaking, for example.